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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. MODULAR HANDLE, T NON- RATCHETING TLR 90 IN-LBS; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
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ZIMMER BIOMET SPINE INC. MODULAR HANDLE, T NON- RATCHETING TLR 90 IN-LBS; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 3572-2
Device Problem Calibration Problem (2890)
Patient Problem No Patient Involvement (2645)
Event Date 02/11/2019
Event Type  malfunction  
Manufacturer Narrative
Udi number: ni.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
 
Event Description
It was reported that the torque output of a torque limiting handle was found outside of the adequate performance range.This was detected during a preliminary calibration check by zimmer biomet spine personnel.There are no specific surgical procedures associated with this handle.
 
Manufacturer Narrative
Additional information: the returned device was evaluated.The torque output was confirmed to be outside of the range.The cause of this issue is likely attributed to a lack of regreasing/relubrication from repetitive use.A review of the manufacturing records did not identify any issues which may have contributed to this event.
 
Event Description
It was reported that the torque output of a torque limiting handle was found outside of the adequate performance range.This was detected during a preliminary calibration check by zimmer biomet spine personnel.There are no specific surgical procedures associated with this handle.
 
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Brand Name
MODULAR HANDLE, T NON- RATCHETING TLR 90 IN-LBS
Type of Device
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key8413018
MDR Text Key138555920
Report Number3012447612-2019-00117
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number3572-2
Device Lot Number73GX-026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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